Lead Pharmacist Trainer of Trainers July 5-7, 2006, Bangkok, Thailand

Purpose of the Training/Missions and Goals

Introduction to Clinical Trials

Good Clinical Practice/Good Pharmacy Practice

Network Pharmacy Guidelines

Protocol

Package Insert

Study Drug Formulations, Batches, and Kits

Study Drug Ordering, Shipment and Storage at Main Country Sites

Setting up Pharmacy Files and Study Product Storage at Study Site

Study Drug Labels

Dispensing Study Drug

Study Drug Administration - Case Report Form/Chart Review

Randomization and Emergency Unblinding Procedures

Product Accountability

Destroying Study Drug

Completing Forms and Logs

Transferring Study Drug Between Sites

Developing Pharmacy SOPs

Preparing for Site Specific Training

Study Initiation Training Sep. 19-22, 2006, Jakarta, Indonesia Sep. 26-29, 2006, HCMC, Vietnam Oct. 3-6, 2006, Bangkok, Thailand Oct. 10-13, 2006, Hanoi, Vietnam

SEA Network Overview

Protocol Overview

Informed Consent

Introduction to Case Report Forms

Screening Process

Screening and Enrollment Case Studies

Determining Eligibility and Enrollment Process

Enrollment Procedures

Study Treatment

Daily Assessments

Clinical Failure

Follow up Assessment Visits

Participant Safety

Emergency Unblinding Procedure

Quality Control and SOPs

Site Specific Training Sep. 20 - Oct. 5, Jakarta Oct. 2 - Oct. 9, HCMC Oct. 9 - Oct. 20, Bangkok Oct. 16 - Oct. 20, Hanoi

Case Study #1

Case Study #2

Case Study #3

Case Study #4

Case Study #5

Case Study #6

Case Study #7

Elements of an SOP (handout)

Regional Data Management Center Training Oct. 30 - Nov. 6, 2006, HCMC Nov. 8 - 15, 2006, Bangkok Nov. 8 - 16, 2006, Jakarta

Overview, Security, Citrix/Clintrial Log-in

Clintrial Enrollment

Clintrial Verification, Notes, and Flags

Repeating CRFs

Post-Entry Procedures, Reconciling, and Filing

Clinical Trial Support Specialist Role/Procedures

Batch Processing Clerk Role/Procedures

Data Discrepancy Supervisor Role/Procedures